Negative-pressure wound therapy (NPWT) is a noninvasive therapy that uses negative pressure to treat acute and chronic wounds. NPWT has become a widely used option for treating all types of wounds. When used safely as part of a comprehensive wound treatment program, NPWT has been associated with helping heal wounds. However, while NPWT may be beneficial to patients, complications have been associated with its use. Within two years, the Pennsylvania Patient Safety Authority received 419 reports related to the application or management of negative-pressure wound therapy (NPWT). Complications related to NPWT were described in 112 reports that included bleeding, retained sponges, infection and compromise of tissue surrounding the wound. Seventy-seven patient injuries and six deaths associated with NPWT in two years prompted the U.S. Food and Drug Administration to issue an alert to healthcare providers.
NPWT is thought to help wounds heal by creating a negative-pressure (vacuum) at a well-sealed wound site. This is usually done by inserting foam or gauze dressing into a wound, cavity, or surface; connecting an evacuation tube embedded in the foam or gauze to a vacuum pump; and sealing the area with adhesive tape. The vacuum helps remove fluids and infectious materials and draw wound edges together.
(From the U.S. Food and Drug Administration)
The use of NPWT devices has helped healing and closure of wounds in many patients. Although rare, serious complications, especially bleeding and infection, have been reported in some patients using the devices. These complications can occur in hospitals, long-term care facilities, and at home.
What You Should Know About NPWT
If your doctor has determined that you are a good candidate for using NPWT at home you should:
- Receive adequate training from your doctor, nurse, or home healthcare provider so that you understand how to use your NPWT device. Show your trainer you know how to use NPWT to make sure you are doing it properly.
- Understand the possible complications that may be associated with using your NPWT device. Watch especially for bleeding, which can be life-threatening. If you see signs of bleeding, stop NPWT, apply pressure to the dressing, and seek medical assistance right away.
- Get NPWT patient instructions (labeling) from your doctor, home healthcare provider, NPWT distributor or the manufacturer’s website. Keep these instructions where you can easily find them.
- Talk to your doctor if you do not feel capable of managing the NPWT device at home. He or she might recommend that you have help from an appropriate caregiver.
Questions to Ask Your Healthcare Provider:
Before using NPWT at home, consider asking the following questions:
- Am I using the NPWT device correctly?
- How long should I expect to use the NPWT device?
- What serious complications might occur in my situation?
- What should I do if any of those complications occur?
- Do I need to stop taking aspirin or any other medicines that affect my bleeding system or platelet function? What’s the risk associated with stopping or avoiding such medicines?
- Can you provide me with patient instructions or tell me where I can find them?
Tthe following questions are about complications:
- If complications arise, whom do I contact?
- How do I know if the bleeding is serious?
- How do I know if it is a serious infection?
- How do I know if my wound condition is getting worse?
Reporting Adverse Reactions
Consumers may report adverse drug reactions related to negative-pressure wound therapy to FDA’s MedWatch Adverse Event Reporting Program online, by phone or FAX.
- Online: MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Phone: 1-800-332-1088
- FAX: 1-800-FDA-0178 (1-800-332-0178)
For more information about reporting adverse drug reactions related to NPWT go to the FDA’s website at www.fda.gov, click on “medical devices,” then “device advice,” then “How to Report a Problem”(medical devices) under “Recalls and Alerts.”
For more information about NPWT, go to the 2011 March Pennsylvania Patient Safety Advisory article, “Improving the Safety of Negative-Pressure Wound Therapy,” by clicking here.